Chris Whitehouse, an expert on medical technology policy at Whitehouse Communications updates readers on changes to the timelines for implementation of the EU’s Medical Devices Regulation and highlights the need for the sector to engage with European institutions to avoid regulatory crises.
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Concept of avoiding crisis / danger
A crisis was fomenting in terms of European regulation of medical devices, but it seems last minute action can yet see it averted and manufacturers can breathe a sigh of relief.
The EU has never been renowned for quick decision-making, and the long-awaited implementation of its new Medical Devices Regulation, first enacted back in 2017 but not yet fully implemented, is no exception. The question is whether its provisions are still fit for purpose when assessed against the background of a global pandemic the like of which the EU has never previously seen, and which wasn’t anticipated back when the details of the regulation were agreed.
But, regulators, lawmakers and manufacturers all broadly accept that the new regulation is indeed fit for purpose not only to guarantee safety but also to facilitate innovation. The EU Medical Devices Regulation (MDR) is intended to meet that test. The problem that has come crashing to the fore post-pandemic, however, is that regulators and the third-party organisations that handle medical device assessment under the provisions of the regulation lack the capacity to meet the demand. Delay in implementation has, therefore, come as something of a relief across the sector.
A three-year transitional period was originally planned for the implementation of the key provisions of the MDR, but, last month, the Commission listened to manufacturer concerns and proposed an extension. Understanding the current state of play and future timeline for change are key for medtech developers’ and manufacturers’ future planning.
The MDR replaces the EU Medical Device Directive (MDD). Changes introduced by the new legislation include enhanced safety and performance requirements, technical documentation, and clinical data and evaluation requirements. The legislative change required all medical devices certified under the MDD to be re-certified based on MDR by 26th May 2024. Yet, the substantial shortage of capacity in the “notified bodies” set to undertake this work presented a roadblock to progress which needed urgently to be addressed.
Notified bodies have to date received 8,120 applications from manufacturers and have issued only 1,990 certificates under the MDR. The number of MDR certificates expected to have been issued by May 2024 may still only reach around 7,000 if the current rate of certificate issuance continues with no changes to current conditions – well short of the 22,793 certificates issued under the MDD. The shortfall is massive and rightly set alarm bells ringing.
The Commission has now proposed to extend the transitional period for the certification of medical devices with staggered deadlines depending on the risk class of the device: 2027 for class III and class IIb devices (devices in higher risk categories) and 2028 for class IIa and class I devices (lower risk devices) that need the involvement of a notified body in the conformity assessment.
Fortunately, the Commission’s proposal was supported by European Council members at the Employment, Social Policy, Health and Consumer Affairs’ (EPSCO) session held on 9th December. In terms of next steps, the Commission aims imminently to provide the legislative proposal to the Council and the European Parliament to consider. This needs to happen fast.
The Commission’s Medical Device Coordination Group (MDCG) also published a position paper aiming to achieve a common understanding of and a uniform approach to the application of Article 97 of the MDR. This article foresees that competent authorities can temporarily allow devices that do not comply with the MDR to continue to be placed on the market if they do not present an unacceptable risk to the health or safety of individuals or to public health.
The position paper suggests that Member States apply the safety valve of article 97 in cases where manufacturers make reasonable efforts to obtain certification under the MDR but the conformity assessment by a notified body has not been concluded it time.
With the whole EU, and indeed the wider world, wanting to see more rapid and effective medical device regulation, action was clearly essential to avoid the sector grinding to a halt. But businesses cannot afford to take their eyes off the ball.
Regulators and lawmakers had several years to see this crisis coming, but, whilst it is perhaps at the 11th hour, at least engagement has on this occasion ensured that the crisis can be averted.
Questions about or comments upon this article can be addressed to the author at chris.whitehouse@whitehousecomms.com.
